Category Archives: Food & Drug Administration

The House and the Senate have begun deliberations on funding levels for NIH, CDC, AHRQ, NSF and FDA for FY15. Pressure to cut federal spending this midterm election year is enormous, and we need advocates to reach out to their representatives. Members in both houses of Congress are accepting input from constituents on which priorities they should fight for. Let your representatives know that combating disabling and deadly diseases is a national imperative, and funding for the agencies committed to this fight should be included on their list of appropriations priorities. Contact them TODAY and share this alert on Facebook, Twitter and with your networks.

The president’s budget does not reflect the potential the U.S. has to advance scientific discovery. While welcome, the minor increases for the National Institutes of Health, the National Science Foundation, and the Food and Drug Administration diminish our ability to accelerate the pace of medical innovation, which saves countless lives, helps our nation meet its solemn commitment to wounded warriors, and is a major driver of new businesses and jobs. We’re also disappointed with reduced funding for the Agency for Healthcare Research and Quality and the Centers for Disease Control and Prevention. AHRQ and CDC cannot be neglected in the name of deficit reduction, and it is truly disturbing that the president’s budget treats those crucial agencies in that manner. The capacity to improve health outcomes and health care efficiency, stem the explosion in chronic diseases, and protect the security of our nation in the face of lethal, drug-resistant infections and international pandemics all hinge on the expertise and resources available to these agencies. We must expand investigations into cancer clusters, deadly meningitis outbreaks and research crucial to bioterrorism preparedness, not reverse course. These funding levels also jeopardize our global leadership in science — in effect ceding leadership to other nations as they continue to invest in strong R&D infrastructures that have already begun to attract our best and brightest innovators. We simply cannot sustain our nation’s research ecosystem, combat costly and deadly diseases like Alzheimer’s and cancer, and create quality jobs with anemic funding levels that threaten the health and prosperity of Americans. The administration and Congress must work together to boost funding for federal research and health agencies in FY15 and end the sequester in order to truly meet the level of scientific opportunity.

People everywhere are captivated by the world-class athletes competing at the Winter Olympics. The personal commitment, dedication and motivation on display is certainly an essential ingredient for medalling, but it is not sufficient: Each nation fielding a team must commit to supporting sustained excellence. And both the public and private sectors play a role. There are some interesting parallels to science and innovation — we don’t see it in the public eye every day but when it comes to the fore, it’s the kind of success that affirms the human spirit in a compelling way. When lives are saved with a new therapy or new vaccine, we all take heart and we celebrate, perhaps not realizing that it took years of training, teamwork and ‘practice’ to arrive first at the finish line. What it takes to remain internationally competitive in any global arena — very much including science and innovation — is the combination of well-trained and dedicated people at the top of their form, plus a firm national commitment over a many-year period.

In journalistic coverage that we don’t see often enough, a special report in Monday’s Washington Post describes how government-funded basic research has led to new cancer therapies and a potential “cancer vaccine” currently undergoing testing in the private sector. This is a perfect example of the well-honed teamwork that is our public-private sector research enterprise. But without public sector financing, private sector capital and a commitment to STEM education, the pipeline will not only dry up, its infrastructure will crumble. As Congress readies itself to receive and respond to the president’s budget in early March, email your representatives in Washington to let them know that when it comes to medical research and innovation, the U.S. must continue to go for the gold. That means recommitting to global leadership.

With long-standing champions of science retiring, spurring that commitment will undoubtedly be a steeper climb. Congressman Rush Holt, a physicist whose legacy in Congress as a champion for science, research and STEM education is truly superlative, announced his retirement on Tuesday. His is the latest retirement in a string that reminds us how pivotally important one Member of Congress can be in advancing the best interests of our nation, and it underscores the importance of cultivation of new champions.

Tomorrow morning several NIH directors (NINDS, NICHD, NHLBI and NIAMS) will appear on C-SPAN’s Washington Journal. The call-in program airs from 7:30 – 9:30 a.m. Eastern. I hope you take advantage of participating in this nationally broadcast program. Ask the directors what they think it will take to assure gold-medal winning research now and in the years ahead! Here are the Washington Journal’s phone numbers for calling in tomorrow:

Ironically, the government is closed down today. But that’s due to a major snowstorm, not because of failure to agree on increasing the debt limit! Agreeing to increase the debt limit is an encouraging sign that this Congress, weighed down as it is by ideological and political differences, and with record- low approval rankings from the public, can get its job done! Our job is to be sure research is a top priority in this election year — spoken of with conviction by all candidates and by the media and others who influence them.

Standing tall among Members of Congress who champion science are the Chair and Ranking Member of the House Appropriations’ Commerce, Justice, Science and Related Agencies subcommittee, Rep. Frank R. Wolf (R-VA-10) and Rep. Chaka Fattah (D-PA-02). At our upcoming March 12 Advocacy Awards dinner, Research!America will honor Reps. Wolf and Fattah with the Edwin C. Whitehead Award for Medical Research Advocacy, saluting their tireless efforts to champion policies that promote federal and private sector medical research and innovation. Be sure to join us!

Robert Samuelson observes in The Washington Post that Congress, whether by action or inaction, is making too many decisions “on the sly,” without real public awareness or comprehension. Samuelson says that in so doing Congress is compromising priorities like defense and medical research while simultaneously failing to address tax and entitlement reform. I think it is telling that he chose to identify the loss of purchasing power by the NIH as one of three critical problems created as our elected representatives fail to find a clear path through the ideological storm. One of these days they will make those major decisions, and that’s when it will pay off that research has been well-positioned as a top national priority. We must continue to make the case and make it forcefully.

Even as we work to keep our issue in the forefront of big-picture policy change, we must at the same time make our case via the appropriations process, which is proceeding, for the first time in years, according to ‘regular order.’ Right now, in FY14, funding for NIH is lower than in FY12 (and in constant dollars is lower than FY03!) — a shortfall that makes absolutely no sense if the goal is to serve the best interests of America and Americans. Other science agencies are underfunded as well, and the policy environment for private sector research and innovation is not compatible with our nation’s goals of global leadership. As you prepare to pound the pavement and take to social media to make the case to appropriators for research, take inspiration and new data from the following:

Strong arguments for changing course by Dr. Claire Pomeroy, president of the Albert and Mary Lasker Foundation in The Huffington Post.

Creative, unique short videos demonstrating the importance of federal investments in biomedical and biological science from the winners of FASEB’s second Stand Up for Science Video Competition.

And this: According to the National Retail Federation, Americans are expected to spend $17.3 billion in celebration of Valentine’s Day. That amount would fund the National Heart, Lung and Blood Institute for more than five years! We are a wealthy nation; we can well afford to spend more on the future of health than we currently are.

Since President Obama declared 2014 as a “year of action” in his State of the Union address, several people have asked my view on how the president might advance science by executive order. Some options that come to mind: the president can (1) pump up the budget for NIH and other science agencies in his FY15 budget blueprint, scheduled for release in early March; (2) require an assessment of the impact on innovation, access and economic growth before making any administration-initiated cuts to drug, biologic or device reimbursement; and (3) designate a task force to formulate a national science strategy.

As several Members of Congress noted after the president’s address, American progress can’t be achieved solely by executive order. But rather than debating constitutional authority, it’s past time for the administration and Congress to work together to advance the priorities of the Americans who hired them. Congress is reportedly getting a jump-start on the FY15 appropriations process, so this is perfect timing for advocates to make the case for science funding levels that capitalize on the multi-faceted return on that investment. Continue reading →

During his State of the Union address Tuesday, President Obama acknowledged the important role federally funded research plays in maintaining our global competitive edge and referenced the harm done to basic science by sequestration. Using the example of vaccines, he highlighted the importance of applied research, not only for our health but for the strength of our economy. See my statement about the address here. For the president to succeed in achieving a “breakthrough year for America” — a theme in his address that he is repeating in appearances across the nation — we urge him to put science and innovation at the forefront. I emphasized this in a letter we sent to him today.

During the State of the Union Congressional Debrief sponsored by The Atlantic and National Journal, I asked Rep. Diana DeGette (D-CO-01) whether Congress would work with the president to undo the damage done to basic research. She said that she and others are working in a bipartisan way to assure that “America is the top nation for research in the world.” In an effort to combat the underfunding and underappreciation for federally funded science, our award-winning voter education initiative is launching shortly — “Ask Your Candidates! Is Medical Progress a Priority?” It is critical that we all ask congressional candidates their views about assuring medical progress. I encourage you to participate in this important campaign as we enter the primary and then general election season.

Last week, the attention of the business community and other leaders was trained on Davos, Switzerland. Comments by Harvard economist Larry Summers at the World Economic Forum put U.S. underinvestment in medical progress into context. It’s a message worth repeating. “We are spending 25 [percent] less on research in the life sciences than we were five years ago. That is a deficit with huge human consequences. We have to move on from viewing deficits in terms of financial debt and focus on the deficits we are bequeathing to our children.”

Please join me in extending hearty congratulations to Research!America Chair and former Congressman John Edward Porter, who will receive the National Academy of Sciences’ most prestigious award, the Public Welfare Medal, at a ceremony this spring. This award, rarely given to a non-scientist, recognizes John for decades of advocacy on behalf of medical research and salutes his many accomplishments, including leadership in the Congress for medical and all scientific research, resulting in increased federal support of our nation’s science agencies. He continues his leadership for science today!

It’s heartening President Obama chose to emphasize in his speech the significance of federally funded basic research and the need to undo the damage that has been done to it in recent years with deep spending cuts. The president used language the science community epitomizes – he spoke of working for “breakthroughs” and a nation motivated by opportunity. But actions speak louder than words. Congress and the White House must treat research and innovation as the health and economic imperative it has always been and invest in expanding our nation’s research capacity. It bears on business and job creation in both the research and manufacturing sectors; it bears on our nation’s ability to slow or stop the progression of disabling, deadly and federal deficit-perpetuating diseases like Alzheimer’s, cancer and heart disease; and most importantly, it bears on the quality of life for Americans now and in the future. Our elected officials must eliminate sequestration for good and support medical innovation at the level of scientific opportunity to ensure more breakthroughs in coming years.

Anticipating the 2014 State of the Union address next Tuesday evening, I have been searching for the right descriptor — the union is “in a state of resignation”? “The state of the union is not as bad as it could be”? “The union is in a state that falls short of its potential”? “The Americans forming this union are in a state of disappointment regarding their elected leaders”? A headline from The Washington Post last week addresses the latter point: “Congratulations on your budget, Congress. America still hates you,” i.e. no uptick for those low ratings for congresspersons of either party! The president’s rating with the public is a bit better (though not high) as he takes the annual opportunity to discuss the nation’s progress relative to enduring objectives such as economic strength, robust national defense capability, a balanced budget and, implicitly, global leadership and influence. As we all know, the state of our nation’s science and technology enterprise intersects all of these objectives, but the odds are against that point being made. The pols don’t believe there are votes in talking about science, and this year is all about rounding up votes. Yet there are a number of reasons voters should question candidates about their position on research and innovation: because of the good jobs and revenue today; because our global competitiveness in export markets extends into the future; and because medical and human progress remains an enduring and defining contribution that our nation makes to its people and to the world. Continue reading →

The omnibus appropriations bill about to become law demonstrates that bipartisanship and pseudo-regular order is achievable. We won’t know for sure if we have true “regular order” until Congress proceeds through the FY15 appropriations process in a timely manner — something that hasn’t happened for many years. The importance of regular order is that the public’s interests are heard from in hearings, and every Member of Congress participates in priority-setting instead of only having the opportunity to cast a single up-or-down vote. Regular order is worth working toward, since at least one priority we all care about did not fare well in the omnibus.

The omnibus has failed to fund NIH at a level that fully reverses the impact of sequestration on the agency’s baseline funding level, much less establishes a growth trend that can fully unleash the potential inherent in the sequencing of the human genome and other research breakthroughs. As Drs. Paul Stoffels and Alan Leshner make crystal clear in an op-ed in Politico Magazine, we can’t settle for “better than sequestration.” If our nation wants to thrive, we need to grow our investment in science. Between 2010 and 2013, U.S. federal investments in science fell to less than 1% (.82%) of the economy. That’s the lowest it’s been in 50 years! As you know, this comes at a time when foreign nations are rapidly ramping up their R&D programs and taking a page from our playbook. Remember that global competitiveness in medical research is a pivotal determinant of our global economic competitiveness overall. We aren’t just talking about the future of our scientific enterprise, we are talking about the future of our economy. Are we truly willing to cede leadership in global R&D? (See also our statement cited in The Hill and other media outlets, as well as my interview today with UDC.) Continue reading →

We applaud portions of the omnibus bill that support the nation’s research, innovation and public health ecosystem, which works to assure our future health and economic well-being. The growth in funding for the Food and Drug Administration, fueled in part by the common-sense return of the 2013 user fees, as well as the increases for the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality and the National Science Foundation are welcome news.

But funding for the National Institutes of Health has been kept well below the level of scientific opportunity. We must eliminate sequestration once and for all, and grow our investment in NIH in order to slow and halt the progression of diseases and disabilities ranging from Alzheimer’s to diabetes to traumatic brain injury. The appropriators have worked in good faith to move the nation forward. But as long as Congress avoids the primary issues fueling our national debt – tax and entitlement reform – it will be difficult to invest robustly in solutions to our problems.

Following the lead of Budget Chairs Murray (D-WA) and Ryan (R-WI-01), Appropriations Chairs Mikulski (D-MD) and Rogers (R-KY-05) are trying to end the recent string of continuing resolutions and craft a funding compromise that advances the nation’s best interests. Congress may miss its January 15 deadline for appropriations, but it won’t likely shut down the government. We anticipate a short-term extension of the deadline while appropriators in both chambers work to craft an omnibus bill that reflects today’s priorities instead of blind, across-the-board cuts. It’s about time, you’re thinking (and I agree!) that Congress gets back to “regular order.” Regular order includes listening to constituents, content experts and advocates. That’s where you come in. Here is a link to the appropriators and the contact information for their legislative directors (LDs). Emailing their LDs may be the fastest route to reaching the members themselves. Tell them that you endorse their determination to appropriate in keeping with national priorities — and tell them what your priorities are. Continue reading →

Recently, progress has been made in Congress that must not be confused for victory but is momentum to be capitalized on. For instance, the bipartisanship and compromise that we’ve seen in Congress is the first step in a long journey that is necessary for medical and health research to flourish and which provides temporary relief from sequestration. Now is the time to carry forward.

Advocates cannot tiptoe around other far-reaching truths: Our global competitiveness is at risk, young scientists are leaving the profession as fewer grants are awarded, Americans are dying, health care costs are exploding, and the facts prove it. Investing in innovation, at levels set to match and exceed scientific opportunity, is the best way to improve the well-being (both health and economic) of future generations. Send a message to Congress now to maximize funding for agencies that sponsor medical and health research!

As the year comes to an end, let’s revisit the top ten most popular Research!America blog posts in 2013 (based on page views) that highlighted the importance of making research for health a higher national priority. We’re thankful for our many outstanding guest bloggers including early career scientists, leaders of industry, academia, patient groups and scientific societies who strongly believe in the promise of scientific discovery and medical innovation to build healthier lives.

10) Millennials Move On

August 14: Guest blog post by Tyler Wiechman on why the millennial generation is leaving science, from his personal experience. “If funding was more available for these VITAL research programs, students of this generation would be much more optimistic about their personal future in clinical research and able to get into academia or the industry of their choice.” Read the post, here.

9) The Science Policy Group at the University of California, San Francisco

July 22: The Science Policy Group at UCSF speaks out about the “crisis situation” brought about by the sequester. “We have observed a number of our postdoctoral colleagues leave UCSF due to the budgetary constraints both they and their PIs were experiencing. The immediate consequences, such as sudden lay-offs and premature termination of promising research careers, are obviously tragic.” Read the post, here.

8) Research!America Hosts NTD Forum at Tulane University

May 17: Neglected tropical diseases (NTDs) commonly associated with the developing world, have been identified in many parts of the country including Louisiana. Research!America hosted an NTDs event at the Tulane University School of Public Health and Tropical Medicine in New Orleans with health and policy experts. Read highlights of the event, here.

7) Research!America’s Inaugural Advocacy Academy

September 19: Highlights of the inaugural Advocacy Academy which brought 12 postdoctoral researchers from across the U.S. for a two-day advocacy training program in Washington, D.C. that culminated in Capitol Hill visits with their representatives. Read the post (and see photos), here.

6) Public Health Thank You Day, November 25

November 6: Every year, Research!America and other leading health organizations take time to recognize the public health professionals across the country who protect us from disease and injury. The 2013 Public Health Thank You Day blog post describes the round-the-clock activities to address major health threats and promote good health. Learn more about the initiative, here.

April 24: Research!America produced two short compelling videos about neglected tropical diseases and patients with NTDs that were unveiled at the NTDs Louisiana event (see post #8). Watch the videos, here.

4) Top “disruptive technologies” that could revolutionize health care and research

May 30: Blog post about a McKinsey Global Institute’s report that identified 12 “disruptive technologies” that could be transformative for the U.S. economy. “It doesn’t take much imagination to see many of these technologies making an indelible mark on health care and public health.” Sound interesting? Read the post, here.

3) Announcing Research!America’s Inaugural Advocacy Academy

June 4: The third most popular post of 2013 was the announcement of the Research!America’s Inaugural Advocacy Academy which focused on engaging early-career scientists in research advocacy and science policy. The program is an opportunity for postdoctoral fellows to learn how to incorporate advocacy and effective communications into their role as a scientist. (see post #7). Take a look, here.

2) Cuts to NIH research squeezes young scientists out

July 25: The second most viewed; op-ed by Abigail Schindler, PhD, postdoctoral fellow at the University of Washington, Department of Psychiatry and Behavioral Sciencesand co-leader of the Seattle Forum on Science Ethics and Policy published in The Seattle Times. Abigail bemoaned the consequences of sequestration (across-the-board budgets cuts) to science and the careers of young scientists. Read more here.

1) Heroes for scientific knowledge

October 23: Our most popular post of the year! Benjamin Caballero MS, a PhD candidate at the Albert Einstein College of Medicine (one of the Research Matters Communications Workshop participants) wrote this entry about theimportance of scientists communicating their research to the public and policy makers.

“Science is in need of heroes. It is important to realize that each and every one of us have a role and can become one. Inform yourself, ask questions to the experts and learn how your day-to-day life is benefited from the scientific endeavor. Be a part of human progress, become the hero science needs.”

The end of the year is a good time to think ahead and consider our nation at the end of the decade; how will we fare in the world order? My letter this week to the editor of the New York Times highlights poll data indicating that Americans don’t believe the U.S. will be the world leader in science and technology by 2020. This data reflects opinions grounded in numerous media reports on China’s accomplishments and determination to lead the world in science. Chinese accomplishments in space of late and their plans for a space station in 2020 ought to be a 21st century “Sputnik moment” for the U.S. It should be a wake-up call to policy makers: get serious about fueling our nation’s underpowered research and education infrastructure if we expect to compete globally in the years ahead. As NIH Director Dr. Francis Collins noted in his Washington Post op-ed this week, we’re at a “critical juncture” in biomedical research. Do we pursue opportunities derived from recent medical breakthroughs or squander them with insufficient funding for research? Continue reading →

Here’s a holiday surprise! I am not referring to the budget deal, but to the fact that Merriam-Webster’s 2013 word of the year — determined via the greatest increase in online searches — is “science.” I find this to be refreshing news, providing evidence that interest in science is growing, which in turn is an indication of substantial room for researchers and research advocates to contribute to public understanding and support of science. We appear to have an opportunity ready for the taking to overcome the “invisibility” problem that contributes to holding decision makers back from assigning a higher priority to science.

And speaking of those decision makers, we have a budget deal! While modest at best, it is a starting point for bipartisanship in serving the public’s interest. We can build on this foundation. Please add your voice, as funding is being determined by appropriators. Click here to urge your Members of Congress to support robust funding for NIH, NSF, FDA, CDC and AHRQ. This week, we’ve released our annual Health R&D Investment report, which could provide new context for your messages. The report shows some gains in philanthropy, industry, and voluntary health association support for research but notes woefully inadequate federal funding, especially given what’s at stake for our health and our economy. Continue reading →